Device for liquid medical substance venous administration

ABSTRACT

A method for administering a liquid medical substance in a vein. The method comprises inserting a plurality of tubular ducts into a target venous lumen, conducting a liquid medical substance via at least one of the plurality of tubular ducts ( 106, 215, 419, 602 ) for the administering thereof toward a venous wall ( 110, 410 ) at the target venous lumen in an ejection pressure, quantity and direction, and withdrawing a residue of the liquid medical substance from the target venous lumen, in a suction pressure, quantity and direction, for the conducting thereof via at least one different of the plurality of tubular ducts ( 130, 240, 400 ). A relation between the ejection pressure, quantity and direction and the suction pressure, quantity and direction limits the extent of the administering within the venous lumen to a predefined space.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/918,331 filed on Aug. 19, 2010, now U.S. Pat. No. 8,361,008, which isa National Phase of PCT Patent Application No. PCT/IL2009/000197 havingInternational filing date of Feb. 19, 2009, which claims the benefit ofpriority of U.S. Provisional Patent Application Nos. 61/050,644 filed onMay 6, 2008, and 61/029,930 filed on Feb. 20, 2008. The contents of theabove applications are all incorporated herein by reference.

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to methodand device of administering liquid medical substances and, moreparticularly, but not exclusively, to method and device of administeringliquid medical substances in blood vessel.

Administration of liquid medical substances directly into venous lumenfor treating blood vessels, for example for sclerotherapy, has beenpracticed for a number of years.

For example, sclerotherapy is used for eliminating large spider veins(telangiectasiae) and smaller varicose leg veins. The sclerosingsolution closes the “feeder veins” under the skin that are causing thespider veins to form, thereby making a recurrence of the spider veins inthe treated area less likely. Sclerotherapy can also be performed usingsclerosants, such as microfoam sclerosants, under ultrasound guidance totreat larger varicose veins, including the great and small saphenousveins, see Paul Thibault, Sclerotherapy and Ultrasound-GuidedSclerotherapy, The Vein Book/editor, John J. Bergan, 2007, which isincorporated herein by reference. After a map of the patient's varicoseveins is created using ultrasound, these veins are injected whilstreal-time monitoring of the injections is undertaken, also usingultrasound. The sclerosant can be observed entering the vein, andfurther injections performed so that all the abnormal veins are treated.Follow-up ultrasound scans are used to confirm closure of the treatedveins, and any residual varicose veins can be identified and treated.

One of the limitations sclerosing treatments for veins the concentrationof the used sclerosing agents in certain target blood vessels. Forexample, some regulatory limitations restrict the concentration ofsclerosing agents to less than 3% concentration if the target vein isless than 4 mm in diameter. In such concentrations, the sclerosing agentis rapidly diluted and therefore not sufficiently effective for treatingthe surrounding veins. Increasing the quantity and/or the concentrationof the injected sclerosing agent to offset the dilution may introduceharmful quantities into the body.

It should be noted that foaming techniques have also been tried to treatveins using sclerosing agents. The delivering of sclerosing agents in afoam form at least partially offsets the effect of the sclerosantdilution. However, significant harmful effects resulting from the foamedsclerosants have been evidenced, in particular blood clotting throughoutthe vascular system, wherever the foamed sclerosant has reached.

Few devices and method have been developed for improving theadministration of liquid medical substances, such as sclerosing agents,into the veins. For example, International Patent Application No. WO2006/017470A2, published on 16 Feb. 2006, which is incorporated hereinby reference describes a device and method for treating bodily diseasesand/or conditions, for example, varicose veins, tumors and aneurismsincluding for example insertion of a blocking device toward a targetdestination using an intrabody device, such as a catheter, and deliveryof sclerosing or other agents to the vessel while maintaining minimal,for example zero pressure in the treatment area. The blocking device mayprevent treatment materials, embolisms, debris and the like fromentering the upstream section of vessel. The blocking device mayinclude, for example, a cap or other concave shape and may be expandableor extendible towards the vessel walls.

SUMMARY OF THE INVENTION

According to some embodiments of the present invention there is provideda method for administering a liquid medical substance in a vein. Themethod comprises inserting a plurality of tubular ducts into a targetvenous lumen, conducting a liquid medical substance via at least one ofthe plurality of tubular ducts for the administering thereof toward avenous wall at the target venous lumen in an ejection pressure, quantityand direction, and withdrawing a residue of the liquid medical substancefrom the target venous lumen, in a suction pressure, quantity anddirection, for the conducting thereof via at least one different of theplurality of tubular ducts. A relation between the ejection pressure,quantity and direction and the suction pressure, quantity and directionlimits the extent of the administering within the venous lumen to apredefined space.

Optionally, the liquid medical substance comprises a sclerosing agent.

More optionally, the sclerosing agent concentration is lower than 5percent.

Optionally, the withdrawing and the administering are performedsimultaneously.

Optionally, the withdrawing is performed a predefined period after theadministering being completed.

Optionally, at least one of the ejection pressure, quantity anddirection and the suction pressure, quantity and direction is performedaccording to a characteristic of the target venous lumen.

Optionally, the ejection direction is substantially perpendicular tomovement axis of the venous wall.

Optionally, the administering is performed in a plurality of ejectiondirections.

Optionally, the plurality of tubular ducts are connected to an intrabodydevice tip at least one of the administering and withdrawing isperformed via the intrabody device tip while the intrabody device tipbeing in motion.

Optionally, at least one of the administering and withdrawing isperformed in a helical pattern having a central axis substantiallyparallel to the venous wall.

Optionally, the administering comprises substantially blocking a bloodflow in the target venous lumen.

Optionally, the withdrawing is applied from a plurality of suctiondirections.

More optionally, wherein a first of the plurality of suction directionsis directed toward a first edge of the venous lumen and a second of theplurality of suction directions is directed toward a second edge of thevenous lumen.

According to some embodiments of the present invention there is providedan intrabody device for administering a liquid medical substance in avein. The intrabody device comprises at least one outlet and at leastone inlet, an ejection force source connected to at least one tubularduct and configured for applying an ejection force for conducingtherethrough a liquid medical substance to the at least one outlet foradministering the liquid medical substance at an ejection pressure,quantity and direction, and a suction force source connected to at leastone tubular duct and configured for applying a suction force forwithdrawing therethrough a residue of the liquid medical substance fromthe at least one inlet in a suction pressure, quantity and direction.When the at least one inlet and outlet are in a venous lumen and arelation between the ejection and suction pressure, quantity anddirection limits the extent of the liquid medical substance within thevenous lumen to a predefined space.

Optionally, the intrabody device further comprises an ejection channelwith the at least one outlet and a withdrawal channel with the at leastone inlet at the tip of the intrabody device, the withdrawal channel ispartly encircled by the ejection channel.

Optionally, the at least one inlet comprising a plurality of inlets, theat least one outlet is positioned between at least two of the pluralityof inlets.

Optionally, the intrabody device further comprises a helical ejectionchannel having the at least one outlet positioned therealong.

Optionally, the intrabody device further comprises a helical withdrawalchannel having the at least one inlet positioned therealong.

Optionally, the intrabody device further comprises a filtering elementpositioned in front of the at least one inlet and configured forpreventing from at least one component having a diameter above a certainthreshold from penetrating the at least one inlet.

Optionally, the intrabody device further comprises a filtering elementpositioned in front of the at least one inlet and configured fordetermining at least one of the suction pressure, quantity anddirection.

Optionally, the filtering having a cavity for collecting the at leastone component.

Optionally, the intrabody device further comprises a filtering elementpositioned in front of the at least one outlet and configured fordetermining at least one of the ejection pressure, quantity anddirection.

Optionally, the intrabody device further comprises an intrabody devicetip having a portion having the at least one outlet and an expended andunexpended configurations, wherein a distance between the at least oneoutlet and a venous wall in the venous lumen is reduced when the portionbeing in the expended configuration.

Unless otherwise defined, all technical and/or scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which the invention pertains. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of embodiments of the invention, exemplarymethods and/or materials are described below. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and are notintended to be necessarily limiting.

BRIEF DESCRIPTION OF THE DRAWINGS

Some embodiments of the invention are herein described, by way ofexample only, with reference to the accompanying drawings. With specificreference now to the drawings in detail, it is stressed that theparticulars shown are by way of example and for purposes of illustrativediscussion of embodiments of the invention. In this regard, thedescription taken with the drawings makes apparent to those skilled inthe art how embodiments of the invention may be practiced.

In the drawings:

FIG. 1 is a schematic illustration of an exemplary intrabody device tipfor administering and extracting a liquid medical substance, such as asclerosing agent, according to some embodiments of the presentinvention;

FIG. 2 is a flowchart of a method for administering a liquid medicalsubstance, such as a sclerosing agent, in a limited space in a venouslumen, according to some embodiments of the present invention;

FIGS. 3A-3D are axial sectional views of exemplary intrabody devicetips, according to some embodiments of the present invention;

FIGS. 4A and 4B are schematic illustrations of an intrabody device tiphaving a helical arrangement of a plurality of outlets and/or inlets,according to some embodiments of the present invention;

FIG. 5 is a schematic illustration of the intrabody device tip in FIG. 4and an exemplary helical movement pattern thereof, according to someembodiments of the present invention;

FIG. 6 is a schematic illustration of an intrabody device foradministering a liquid medical substance, such as a sclerosing agent,along a portion of a venous wall and withdrawing the residue of theliquid medical substance from the distal end thereof, according to someembodiments of the present invention;

FIG. 7A is a schematic illustration of an intrabody device tip foradministering a liquid medical substance via a filtering element,according to some embodiments of the present invention; and

FIG. 7B is a schematic illustration of an intrabody device tipwithdrawing a residue of a liquid medical substance, and optionallysurrounding blood and debris, via a filtering element, according to someembodiments of the present invention.

DESCRIPTION OF EMBODIMENTS OF THE INVENTION

The present invention, in some embodiments thereof, relates to methodand device of administering liquid medical substances and, moreparticularly, but not exclusively, to method and device of administeringliquid medical substances in blood vessel.

According to some embodiment of the present invention there is provideda method for administering a liquid medical substance, such as asclerosing agent, in a vein. The method may be implemented using anintrabody device, such as a catheter, having an insertion tube with aplurality of tubular ducts which is inserted into a target venous lumen.Such a positioning allows administering a liquid medical substancetowards a venous wall at the target venous lumen in an ejectionpressure, quantity and direction which optionally predefined. Inaddition, optionally simultaneously, alternatively, and/or sequentiallya residue of the liquid medical substance is drawn from the targetvenous lumen, for example together with blood and debris. Thewithdrawing is performed via one or more of the inserted plurality oftubular ducts in a suction pressure, quantity and direction, which isoptionally predefined. The relation between the ejection pressure,quantity and direction and the suction pressure, quantity and directionlimits the extent of the administering of the liquid medical substancewithin the venous lumen to a predefined space.

According to some embodiment of the present invention there is providedan intrabody device, such as a catheter, for administering a liquidmedical substance in a vein. The intrabody device comprises one or moreoutlets and inlets, for example situated in a distal end of thecatheter. The intrabody device comprises an ejection force source, suchas a piston, which is connected to one or more tubular ducts andconfigured for applying an ejection force for conducing a liquid medicalsubstance through the tubular ducts to one or more of the outlets. Insuch a manner, the administering of the liquid medical substance at anejection pressure, quantity and direction is allowed. The intrabodydevice further comprises a suction force source, such as a piston, whichis connected to one or more tubular ducts and configured for applying asuction force for withdrawing through the one or more tubular ducts aresidue of the liquid medical substance via the one or more inlets in asuction pressure, quantity and direction. When the inlets and outletsare in a venous lumen a relation between the pressure, quantity anddirection of the ejection and the pressure, quantity and direction ofthe suction limits the extent of the liquid medical substance within thevenous lumen to a predefined space.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details of construction and the arrangement of thecomponents and/or methods set forth in the following description and/orillustrated in the drawings and/or the Examples. The invention iscapable of other embodiments or of being practiced or carried out invarious ways.

Reference is now made to FIG. 1 which is a schematic illustration of anexemplary intrabody device tip 99 of an intrabody device, such as acatheter, (not shown) for administering and extracting a liquid medicalsubstance, such as a sclerosing agent, according to some embodiments ofthe present invention. The intrabody device tip 99 is attached at adistal end of the intrabody device, such as a catheter. For clarity, aliquid medical substance means a liquid comprising one or more of thefollowing a sclerosing agent, such as sodium tetradecyl sulfate (STS),polydocanol, and bleomycin, a drug, a medical component, a filling, suchas hyaluronic acid (HA) secretion and collagen, a medical agent and/orany combination thereof. For example, a liquid medical substance may bea medicament for repairing, re-shaping, restructuring, curing,disinfecting, occluding and ablating a target vein, a venous wall 110 ofa vein and/or an organ in a proximity to a target vein. Similartreatments may be performed for vessels, lumen or anatomical areasadjacent to veins. In some embodiments treatments may be implemented intarget vein, for example, perforator vein, varicose vein, spider vein,saphenous vein, varicose-selle vein, a hemorrhoid, and/or a veinablation.

Optionally, the intrabody device tip 99 is connected to an insertiontube having a plurality of tubular ducts which are aligned therealong.One or more of the tubular ducts are tubular administration ducts whichare adapted for conducting fluid, such as a liquid medical substance, tothe intrabody device tip 99. One or more of the tubular ducts aretubular extraction ducts for withdrawing fluid, such as a residue of theconducted liquid medical substance, from the intrabody device tip 99. Asused herein, a residue of the liquid medical substance means a liquidmedical substance which has been administered via the intrabody devicetip 99 and is present in the venous lumen in proximity to the intrabodydevice tip 99, for example the blood which is blended, mixed, and/ordiluted with the administered liquid medical substance, the liquidmedical substance which have been released from the venous walls 110after a reaction therewith, the liquid medical substance which have notbeen in contact with the venous walls 110 and/or any solution thatincludes a residue of the liquid medical substance.

Optionally, the intrabody device tip 99 comprises an administrationchannel 100, such as a needle, for introducing the liquid medicalsubstance in a venous space. The administration channel 100 forms atubular administration duct 106 which is connected to conducting ductsof the insertion tube of the intrabody device, such as a catheter.Optionally, the tubular administration duct 106 comprises a plurality ofoutlets 115, such as apertures or nozzles, for example 0.4-1.2 mmdiameter holes, for administering the liquid medical substance inproximity to the venous walls. For example, the plurality of outlets 115may be substantially perpendicular to the main axis of theadministration channel 100, which is directed toward the venous walls.

In such a manner, liquid medical substances, such as sclerosing agents,are released toward the venous walls 120, in proximity to a targetvenous wall, and do not get away to other organs, tissues and/or bloodvessels. In addition, by using a plurality of outlets 115 which aredirected toward a venous wall, the released liquid medical substance maybe in relatively low concentration and still affect the venous walls asthe blood in the venous lumen does not substantially dilute releasedliquid medical substance before it contacts the venous walls.

The intrabody device tip 99 comprises an extraction channel 130configured for withdrawing the released liquid medical substance, forexample with blood and/or debris, from the proximity of the venouswalls. Optionally, the administration channel 100 is encircled by theextraction channel 130. Optionally, the axial shape of theadministration channel 100 is a cross or a star with a plurality ofprojections, for example as shown at 105. In such a manner, one or morelumens between the inner walls of the extraction channel 130 and theouter walls 125 of the administration channel 100 are maintained.

In some embodiments of the present invention, the administration channel100 administers the medical substance is a selected ejection pressure,quantity and direction and the extraction channel 130 draws the residueof the medical substance is a selected suction pressure, quantity anddirection. In such a manner, the released liquid medical substance doesnot get away from a limited space at the venous lumen, around theintrabody device tip 99, for example a limited space of 1 cubiccentimeter, 2 cubic centimeter, 3 cubic centimeter, 4 cubic centimeterand/or any intermediate or smaller space which is centered around any ofthe outlets.

Optionally, the ejection pressure, quantity and/or direction and thesuction pressure, quantity and/or direction may be determined accordingto clinical experiments and/or a numerical simulation of the medicalsubstance in various venous lumens. Optionally, the ejection pressure,quantity and/or direction and/or the suction pressure, quantity and/ordirection are determined according to the target vein in which theadministration is performed. As different veins have differentcharacteristics, such as width and/or an estimated blood flow, thepressure, quantity and/or direction of the suction and/or ejection maybe changed. For example, the ejection pressure, quantity and/ordirection and/or the suction pressure, quantity and/or direction may beset differently at the great saphenous vein or at the small saphenousvein.

Reference is now made to FIG. 2, which is a flowchart of a method foradministering a liquid medical substance, such as a sclerosing agent, ina limited space in a venous lumen, according to some embodiments of thepresent invention.

First, as shown at 151, one or more tubular administration ducts andtubular extraction ducts are inserted into a target vein. For example,the tubular ducts may be channels of an intrabody device, such as acatheter. Optionally, a tubular administration duct is a channel havinga first diameter and positioned in a tubular withdrawing duct, such aschannel having a second diameter, which is larger than the first averagediameter or vice versa.

As shown at 152, one or more tubular administration ducts allows theconducting of a liquid medical substance for the administration thereofinto a target venous lumen in the target vein, for example via theadministration channel 100, as shown at 153. The tubular administrationduct is connected to the aforementioned administration channel 100 andallows the administering of the liquid medical substance in a limitedspace, for example as described above.

It should be noted that an estimated response of the target vein to thepresence of the intrabody device, such as a catheter, in the vein is acollapse of the venous walls 110 toward the intrabody device tip 99 andthe intrabody device, such as a catheter's insertion tube. Such acollapse brings the venous walls towards the outlets 115 of theadministration channel 100 and allows releasing the liquid medicalsubstance, which are optionally a sclerosing agent, substantially inproximity to the venous walls. For example, a vein treatment proceduremay include maneuvering and/or positioning the intrabody device, such asa catheter, such that the vein may be responsively collapsed, therebycausing direct contact between the intrabody device tip 99 and thevenous walls. In such an embodiment, application or administration ofthe sclerosing agent substantially adjacently to the venous walls 140may rapidly and/or more effectively trigger irritation, inflammation,and/or destruction thereof. In addition, the short distance between theoutlets venous walls 140, which is optionally less than 2 millimeter or1 millimeter during the administration, may allow using a relativelysmall quantity and/or low concentration of the released sclerosingagent.

As shown at 154, simultaneously and/or sequentially the tubularextraction ducts are used for withdrawing, via the extraction channel130 at the tip of the intrabody device 99, such as a catheter, a residueof the liquid medical substance from the limited space that confines thetarget venous. Optionally, the withdrawing is performed by applying asuction force into the target vein in proximity to the limited space. Insuch a manner, the withdrawing limits the administering to the limitedspace. The suction force may be applied by a piston and/or any otherrespective mechanism. The direction of the suction force is optionallydefined by the inlets of the extraction channel 130. The pressure of thesuction force and/or the quantity of the drawn residue are optionallydefined by the diameter of the extraction channel 130, the diameter ofthe one or more ducts which are connected to the extraction channel 130and/or the diameter of the inlets.

Optionally, the withdrawing 154 and the administering 153 are controlledby an intrabody device, such as a catheter, controller mechanism, suchas a dual syringe. For example, the intrabody device, such as acatheter, controller mechanism may initiate a release procedure in whicha liquid medical substance is pushed via the administration channel 100and the residue of the liquid medical substance is drawn via anextraction channel 130 simultaneously, sequentially, alternatively,and/or according to a predefined releasing and/or withdrawing pattern.

As depicted in FIG. 1, the extraction channel 130 may surround theadministration channel 100. In such an embodiment, the lumen between theextraction channel 130 and the administration channel 100 is used forwithdrawing the residue of the liquid medical substance from the limitedspace that confines the target venous.

Reference is now also made to FIGS. 3A-3D; each is an axial sectionalview of an exemplary intrabody device tip, according to some embodimentsof the present invention. As depicted in FIGS. 3A-3D and in FIG. 1, theextraction channel 130, which is positioned in the extraction channel130, has an axial sectional profile of a cross or a star, such as a 3projections star, a 4 projections star, a 6 projections star, and an 8projections star. The outlets the extraction channel 130 are optionallypositioned on the tip of each one of the respective projections of theaxial sectional profile, for example as shown at 115. In such a manner,the liquid medical substance is released toward the inner venous walls,for example as indicated by arrows 120.

The axial shape of the administration channel 100 may prevent kinks ortwists of the extraction channel 130 as the projections of theadministration channel 100 supports the positioning of the walls of theextraction channel 130 during the introduction of the intrabody devicetip into the target vein.

It should be noted that the axial sectional profile of theadministration channel 100 and/or the extraction channel 130 may bedifferent, creating various ducts for extracting the residue of theliquid medical substance, optionally with surrounding blood and/ordebris.

Optionally, the administration is performed after blocking one or moresides of the target vein, for example using a blocking device such asdescribed in International Patent Application No. WO 2006/017470A2,published on 16 Feb. 2006, which is incorporated herein by reference.

Optionally, the administering 152 and/or the withdrawing 153 areperformed while moving the intrabody device tip along the target vein.For example, the administering 152 and/or the withdrawing 153 areperformed during the extraction and/or the insertion of the intrabodydevice tip 99. In such a manner, the area of the treated venous wall isincreased and the residue of liquid medical substance may be removedmore efficiently.

As the withdrawing operation 153 allows removing the residue of theadministered liquid medical substance after the interaction thereof withthe inner venous walls, agents, such as sclerosing agents, may be usedin higher concentrations and/or activity level. The withdrawingoperation 153 is performed before the of the administered liquid medicalsubstance is spread, allowing the removal thereof from the bloodcirculation before a substantial clotting occurs and/or any other damageis caused to the body of a respective patient. For example, non-dilutedor minimally diluted sclerosing agents may be used for sclerotherapy inveins having a diameter of more than 4, 5, and 6 millimeters, such asthe great saphenous vein.

Reference is now made to FIGS. 4A and 4B, which are schematicillustrations of an intrabody device tip 299 having a helicalarrangement of a plurality of outlets 215 on a helical channel 200 foradministering a liquid medical substance 230, such as a sclerosing agentand/or a plurality of inlets (not shown) for withdrawing the residue ofthe administered liquid medical substance, according to some embodimentsof the present invention. Optionally, the arrangement comprises aplurality of outlets 215 which are formed on a helical channel 200 thatis configured for conducting the liquid medical substance, similarly tothe above mentioned administration channel 100. Optionally, thearrangement comprises a plurality of inlets, such as holes or nozzles,for example 0.4-1.2 mm diameter holes, which are formed on a helicalchannel 200 that is configured for withdrawing the residue of theadministered liquid medical substance, similarly to the above mentionedextraction channel 130. It should be noted that if the arrangementcomprises a plurality of outlets 215, the withdrawing may be performedvia an extraction channel 130, such as the aforementioned extractionchannel 130. Optionally, an additional withdrawing duct 240 ispositioned in parallel to the central axis of the helical channel 200.Such an additional withdrawing duct 240 allows withdrawing the residueof the medical substance from the distal end of the intrabody device tip299. In such a manner, the withdrawing limits the administered space tothe venous lumen which is in front of the helical channel 200, which isoptionally a needle shaped conductor with outlets which arranged in ahelical pattern.

If the arrangement comprises a plurality of inlets 215, theadministration may be performed via an administration channel 100, suchas a duct, that is aligned along the intrabody device tip 299 or via acovering channel that covers a portion of the helical channel 200.

As described above, the administering and withdrawing of the liquidmedical substance may be performed during a movement of the intrabodydevice, such as a catheter, along the target vein, for example during anintroduction 251 and/or extraction 250 of the intrabody device, such asa catheter, into and/or from a target vein. Optionally, the intrabodydevice tip 299 is rotated during the movement. The rotating of thehelically arranged outlets 215 during the movement allows releasing theliquid medical substance around a relatively large, optionallycontinuous, surface area of the venous wall 210. As the helicalarrangement is stretched along the horizontal and vertical axes of theintrabody device tip 299, the rotation thereof substantially and/orfully covers an annular surface therearound.

Optionally, the arrangement of inlets is used as an arrangement ofoutlets. In such an embodiment, the withdrawing is similarly performedon a relatively large, optionally continuous, surface area of the venouswall 210.

Optionally, an additionally arrangement of outlets, optionally parallel,is added to the intrabody device tip 299, allowing the release of anadditional liquid medical substance during, before and/or after therelease of the liquid medical substance.

Optionally, the distance between the outlets 215 is less then 3 mm, 2 mmand/or 1 mm. In such a manner, the rotation allows fully cover thevenous wall 210 during the rotation of the intrabody device tip 299.

It should be noted that the movement of the intrabody device tip 299 incombination with the rotation thereof allows covering venous wall 210 ofsubstantially all along the latitudinal and longitudinal axes of atarget vein.

Reference is now also made to FIG. 5, which is a schematic illustrationof the intrabody device tip 299 in FIG. 4A and an exemplary helicalmovement pattern thereof 320, 315, according to some embodiments of thepresent invention. Optionally, the intrabody device tip 299 furthercomprises an external covering channel 330 with a helical track that issized and shaped according to the pattern of the helical arrangement ofinlets and/or outlets and spread along the inner wall thereof. Forexample, if the inlets and/or outlets are extended out from the axialprofile of the helical channel 200, the helical track is turn or twistlike a screw around them. In such a manner, the extraction and/or theinsertion of the intrabody device tip 299 from and/or into the externalcovering channel 300 cause a helical movement of the arrangement, forexample during the insertion of the helical channel 200 into theexternal covering channel 330 and allow a helical administration of themedical device and/or a helical withdrawing of the residue of themedical device.

According to some embodiments of the present invention, the intrabodydevice tip 299 having the helical arrangement of a plurality of outlets215 which is described in FIG. 4A and an additional, optionallysubstantially parallel, helical arrangement of a plurality of inlets(not shown) for withdrawing a residue of a liquid medical substance,such as a sclerosing agent, according to some embodiments of the presentinvention. In such a manner, the rotating of the helically arrangedinlets during the movement of the intrabody device tip 299 allowswithdrawing the residue of the administered liquid medical substancearound a relatively large surface area of the venous wall, similarly tothe described above. As the helical arrangement is stretched along thehorizontal and vertical axes of the intrabody device tip 299, therotation thereof substantially and/or fully covers an annular surfacetherearound.

In use, the administering and withdrawing operations are optionallyperformed in a sequential manner. In such a manner, an administering ofthe liquid medical substance adjacently to a certain venous wall isaccompanied with a withdrawing of the residue of the administered liquidmedical substance adjacently to the certain venous wall. Optionally, aninteraction period during which the liquid medical substance is passingto the walls is practiced between the administering and withdrawingoperations. For example, the interaction period may be a 5 secondsperiod, a 10 seconds period, a 30 seconds period, and/or anyintermediate or longer period.

Optionally, the withdrawing may be performed in a position that isshifted toward the blood circulation direction in the vein. In such amanner, the withdrawing operation may draw portions of the residue whichhave been shifted by the blood flow.

Optionally, the intrabody device tips, which are described above, areused for treatments near various branch veins, such as perforator veins.In such an embodiment, the withdrawing of the residue of a liquidmedical substance, such as a sclerosing agent, may prevent the enteringthereof to larger veins. The withdrawing of the sclerosing agents,together with the surrounding blood and/or debris substantially reducesor eliminates the likelihood of blood clotting, such as from the veinduring the sclerosing procedure.

Reference is now made to FIG. 6, which is a schematic illustration of anintrabody device tip 430 for administering a liquid medical substance,such as a sclerosing agent, along a portion of a venous wall 410 that isparallel thereto and withdrawing the residue of the liquid medicalsubstance from the distal end thereof, according to some embodiments ofthe present invention. In such an embodiment, the administered liquidmedical substance is drawn from the distal end of the intrabody devicetip 430 before arriving to venous spaces which outside of a targetvenous space that is optionally substantially in front of the intrabodydevice tip 430. Optionally, the intrabody device tip 430 comprises anadministration channel 419, which is optionally a channel having anarrangement of outlets 416, optionally helical or annular, foradministering the liquid medical substance along the longitudinal axisof the intrabody device tip 430. The arrangement of outlets 416, whichare optionally nozzles or apertures, are perpendicular the longitudinalaxis of the intrabody device tip 430 and therefore directs the liquidmedical substance towards the venous walls. In addition, the intrabodydevice tip 430 comprises an extraction channel 400, which is optionallya channel having a smaller diameter than the diameter of theadministration channel 419. For example, the diameter of the lumen ofthe extraction channel 400 may be 2 mm-4 mm and the diameter of thelumen of the administration channel 419 may respectively be 6 mm-8 mm.The extraction channel 400 is optionally positioned in theadministration channel 419, allowing the conducting of the drawn residueof the liquid medical substance, optionally together with blood anddebris, simultaneously, alternatively, and/or sequentially to theadministration of liquid medical substance. Optionally, as shown at FIG.6, the extraction channel 400 is a tubular, needle shape device.Optionally, a lumen block 450 is positioned at the distal end of theadministration channel 419, preventing or substantially preventing fromthe liquid medical substance to flow therethrough. Optionally,extraction channel 400 comprises a plurality of inlets in its distal end415 thereof. These inlets are optionally directed toward the venouswalls, allowing the withdrawing of residue of the medial device from theproximity thereof. The directing of the inlets toward the venous wallscreates a withdrawing force which is substantially perpendicular to thelongitudinal axis of the intrabody device tip 430. Such a withdrawingforce may function as a suction wall that does not allow orsubstantially does not allow the passage of liquid medical substanceaway from the distal end of the intrabody device tip 430. Such anembodiment may be used for treating veins in proximity to branch veins,such as perforator veins. Similarly to the described above, such anintrabody device tip allows administering liquid medical substances,such as sclerosing agents, in proximity to the venous walls.

Optionally, the withdrawing operation is performed during theadministration of the liquid medical substance. In such a manner, theliquid medical substance is not or substantially not diluted by theblood. In this way the sclerosing agent, which may be administereddirectly on or near the vein walls, may be relatively effective even isrelatively low concentrations of less than 5%, 3% or 1%. Furthermore,the withdrawing allows the physician to relatively easily control thequantity and the concentration of liquid medical substance that isadministered in adjacent to a certain venous wall. As the blood is drawnfrom the administered area, the physician can determine the amount thatis administered to a certain target tissue more efficiently.

As described above, the withdrawing is performed at the distal end ofthe intrabody device tip 430. In such a structure, withdrawing that isperformed during a movement of the intrabody device tip 430 away fromthe distal end thereof, for example during the pulling out of theintrabody device tip 430, allows collecting residue of a liquid medicalsubstance which have been released along the longitudinal axis of theintrabody device tip 430. Optionally, in use, the administration isperformed along a certain segment of the venous wall, and then,optionally after an interaction period, the intrabody device tip 430moves along the certain segment while the extraction channel 400performs a withdrawing operation.

Reference is now made FIG. 7A, which is a schematic illustration of anintrabody device tip 599 for administering a liquid medical substancevia a filtering element 602, according to some embodiments of thepresent invention. The intrabody device tip 599 is optionally asdescribed in FIG. 1. However, the intrabody device tip 599 comprises anadministration channel with one or more outlets which are covered withthe filtering element 602. Optionally, the filtering element 602 is anexpandable element, for example a mesh of Nitinol strings and/or anyflexible suitable material. Optionally, the filtering element 602 isexpended substantially to the inner diameter of the vein. In such amanner, the administration may be performed in proximity to therespective venous walls. In addition, the filtering element 602 maydetermine a spatial releasing pattern, for example by defining adifferent pattern of releasing holes 615 and/or temporal releasingpattern, for example according to the diameter of the holes thereof.Optionally, the filtering element 602 may comprise a liquid medicalsubstance, such as a sclerosing agent.

Reference is now made to FIG. 7B, which is a schematic illustration ofan intrabody device tip 699 for withdrawing a residue of a liquidmedical substance, and optionally blood and debris, via a filteringelement 665, such as a mesh, a net, and/or a grating, according to someembodiments of the present invention. The intrabody device tip 699 isoptionally as described in FIG. 7. However, the intrabody device tip 699comprises an extraction channel that performs the aforementionedwithdrawing via the filtering element 665. The filtering element allowspreventing from the filtered debris to block the extraction channel orthe duct that is connected thereto and for conducting the residue of theliquid medical substance, blood, and debris away from the target vein.The filtering element 665 collects debris which has a diameter above acertain threshold. Optionally, as described above, the filtering element665 may be expended to touch the venous walls. In some embodiments, thefiltering element 665 may be used to prevent materials in the vein fromentering into the area 670 where the liquid medical substance isadministered. In other embodiments, the filtering element 665 may beused to collect debris in a designated cavity 660 and/or othernon-required elements from within the vein when intrabody device tip 699is polled out from the target vein. For example, the filtering element665 may be expanded to be adjacently positioned to vein walls, and whenpulled backwards against the direction of blood flow, it may collectdrugs, sclerosing agent, and/or other content from within the vein,therefore allowing the target vein or respective venous walls to besubstantially cleaned out of unwanted materials.

It is expected that during the life of a patent maturing from thisapplication many relevant methods and devices will be developed and thescope of the term a sclerosing agent, a liquid medical substance, afiltering element, and an intrabody device, such as a catheter, isintended to include all such new technologies a priori.

As used herein the term “about” refers to ±10%.

The terms “comprises”, “comprising”, “includes”, “including”, “having”and their conjugates mean “including but not limited to”. This termencompasses the terms “consisting of” and “consisting essentially of”.

The phrase “consisting essentially of” means that the composition ormethod may include additional ingredients and/or steps, but only if theadditional ingredients and/or steps do not materially alter the basicand novel characteristics of the claimed composition or method.

As used herein, the singular form “a”, “an” and “the” include pluralreferences unless the context clearly dictates otherwise. For example,the term “a compound” or “at least one compound” may include a pluralityof compounds, including mixtures thereof.

The word “exemplary” is used herein to mean “serving as an example,instance or illustration”. Any embodiment described as “exemplary” isnot necessarily to be construed as preferred or advantageous over otherembodiments and/or to exclude the incorporation of features from otherembodiments.

The word “optionally” is used herein to mean “is provided in someembodiments and not provided in other embodiments”. Any particularembodiment of the invention may include a plurality of “optional”features unless such features conflict.

Throughout this application, various embodiments of this invention maybe presented in a range format. It should be understood that thedescription in range format is merely for convenience and brevity andshould not be construed as an inflexible limitation on the scope of theinvention. Accordingly, the description of a range should be consideredto have specifically disclosed all the possible subranges as well asindividual numerical values within that range. For example, descriptionof a range such as from 1 to 6 should be considered to have specificallydisclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numberswithin that range, for example, 1, 2, 3, 4, 5, and 6. This appliesregardless of the breadth of the range.

Whenever a numerical range is indicated herein, it is meant to includeany cited numeral (fractional or integral) within the indicated range.The phrases “ranging/ranges between” a first indicate number and asecond indicate number and “ranging/ranges from” a first indicate number“to” a second indicate number are used herein interchangeably and aremeant to include the first and second indicated numbers and all thefractional and integral numerals therebetween.

As used herein the term “method” refers to manners, means, techniquesand procedures for accomplishing a given task including, but not limitedto, those manners, means, techniques and procedures either known to, orreadily developed from known manners, means, techniques and proceduresby practitioners of the chemical, pharmacological, biological,biochemical and medical arts.

As used herein, the term “treating” includes abrogating, substantiallyinhibiting, slowing or reversing the progression of a condition,substantially ameliorating clinical or aesthetical symptoms of acondition or substantially preventing the appearance of clinical oraesthetical symptoms of a condition.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination or as suitable in any other describedembodiment of the invention. Certain features described in the contextof various embodiments are not to be considered essential features ofthose embodiments, unless the embodiment is inoperative without thoseelements.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims.

All publications, patents and patent applications mentioned in thisspecification are herein incorporated in their entirety by referenceinto the specification, to the same extent as if each individualpublication, patent or patent application was specifically andindividually indicated to be incorporated herein by reference. Inaddition, citation or identification of any reference in thisapplication shall not be construed as an admission that such referenceis available as prior art to the present invention. To the extent thatsection headings are used, they should not be construed as necessarilylimiting.

What is claimed is:
 1. A method for administering a liquid medicalsubstance in a vein, comprising: inserting an intrabody device having anintrabody device tip and at least one administration duct and at leastone withdrawing duct into a target venous lumen; performing thefollowing while moving the intrabody device tip along said target venouslumen: applying, at a first direction, a medical liquid quantity of aliquid medical substance in an ejection pressure for ablating saidvenous lumen via at least one outlet of said at least one administrationduct in said intrabody device tip for the administering of said liquidmedical substance toward a venous wall at said target venous lumen; andapplying a suction pressure to withdraw at a second direction a residuequantity of a residue of said liquid medical substance from said targetvenous lumen: via said at least one withdrawing duct, said suctionpressure is applied via first and second inlets of said at least onewithdrawing duct in said intrabody device tip; wherein a relationbetween said ejection pressure, said medical liquid quantity and saidfirst direction and said suction pressure, said residue quantity andsaid second direction limits the medical liquid quantity within saidvenous lumen to a limited space of less than 4 cubic centimeter centeredaround any of the at least one outlet while the intrabody device tip ismoved along said target venous lumen; wherein said at least one outletis placed along said at least one administration, between said firstinlet and said second inlet; wherein said withdrawing and saidadministering are performed simultaneously.
 2. The method of claim 1,wherein said liquid medical substance comprises a sclerosing agent. 3.The method of claim 2, wherein said sclerosing agent concentration islower than 5 percent.
 4. The method of claim 1, wherein said withdrawingis performed a predefined period after said administering beingcompleted.
 5. The method of claim 1, wherein at least one of saidejection pressure, quantity and direction and said suction pressure,quantity and direction is performed according to a characteristic ofsaid target venous lumen.
 6. The method of claim 1, wherein saidejection direction is substantially perpendicular to movement axis ofsaid venous wall.
 7. The method of claim 1, wherein said administeringis performed in a plurality of ejection directions.
 8. The method ofclaim 1, wherein said at least one administration duct and at least onewithdrawing duct are connected to the tip of said intrabody device, atleast one of said administering and withdrawing is performed via saidintrabody device tip while said intrabody device tip being in motion. 9.The method of claim 1, wherein at least one of said administering andwithdrawing is performed in a helical pattern having a central axissubstantially parallel to said venous wall.
 10. The method of claim 1,wherein said administering comprises substantially blocking a blood flowin said target venous lumen.
 11. The method of claim 1, wherein saidwithdrawing is applied from a plurality of suction directions.
 12. Themethod of claim 11, wherein a first of said plurality of suctiondirections is directed toward a first edge of said venous lumen and asecond of said plurality of suction directions is directed toward asecond edge of said venous lumen.
 13. An intrabody device foradministering a liquid medical substance in a vein, comprising: acatheter having an insertion tube having plurality of tubular ducts: anintrabody tip having at least one outlet and at least one inlet of saidplurality of tubular ducts; an ejection force source connected to atleast one first tubular duct of said plurality of tubular ducts andapplies an ejection force for conducting therethrough a liquid medicalsubstance to said at least one outlet for administering said liquidmedical substance at an ejection pressure, quantity and direction; and asuction force source connected to at least one second tubular duct ofsaid plurality of tubular ducts and applies a suction force forwithdrawing therethrough a residue of said liquid medical substance fromsaid at least one inlet in a suction pressure, quantity and direction; acontroller mechanism which controls said ejection force source and saidsuction force source to apply simultaneously said ejection force andsaid suction force while said intrabodv device tip is moving along saidvenous lumen, wherein when said at least one inlet and outlet are in avenous lumen and a relation between said ejection and suction pressure,quantity and direction limits the extent of said liquid medicalsubstance within said venous lumen to a predefined space.
 14. Theintrabody device of claim 13, further comprising an ejection channelwith said at least one outlet and a withdrawal channel with said atleast one inlet at the tip of the intrabody device, said withdrawalchannel is partly encircled by said ejection channel.
 15. The intrabodydevice of claim 13, wherein said at least one inlet comprising aplurality of inlets, said at least one outlet is positioned between atleast two of said plurality of inlets.
 16. The intrabody device of claim13, further comprising a helical ejection channel having said at leastone outlet positioned therealong.
 17. The intrabody device of claim 13,further comprising a helical withdrawal channel having said at least oneinlet positioned therealong.
 18. The intrabody device of claim 13,further comprising a filtering element positioned in front of said atleast one inlet and configured for preventing from at least onecomponent having a diameter above a certain threshold from penetratingsaid at least one inlet.
 19. The intrabody device of claim 18, whereinsaid filtering having a cavity for collecting said at least onecomponent.
 20. The intrabody device of claim 13, further comprising afiltering element positioned in front of said at least one inlet andconfigured for determining at least one of said suction pressure,quantity and direction.
 21. The intrabody device of claim 13, furthercomprising a filtering element positioned in front of said at least oneoutlet and configured for determining at least one of said ejectionpressure, quantity and direction.
 22. The intrabody device of claim 13,further comprising an intrabody device tip having a portion having saidat least one outlet and an expended and unexpended configurations,wherein a distance between said at least one outlet and a venous wall insaid venous lumen is reduced when said portion being in said expendedconfiguration.
 23. The intrabody device of claim 13, wherein said atleast one outlet are arranged to allow said administering in a helicalpattern.
 24. The intrabody device of claim 13, wherein said at least oneinlet has a plurality of suction directions.
 25. The intrabody device ofclaim 13, wherein said relation sets the concentration of said liquidmedical substance in said predefined space.
 26. The intrabody device ofclaim 13, wherein said controller mechanism is a dual syringe.
 27. Theintrabody device of claim 13, wherein said inserting induces thecollapse of said target venous lumen.